<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07445161011053</udiDi>
    <basicUdiDi>7445161ErgoroundR5</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ERSC-1050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T05:57:13.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-40100EX</udiDi>
    <basicUdiDi>B-40100EX</basicUdiDi>
    <tradeName>CEREFORM®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Euromi Biosciences</manufacturerName>
    <manufacturerSrn>BE-MF-000020089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CEREFORM</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:05:31.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745120609</udiDi>
    <basicUdiDi>B-04046745120609</basicUdiDi>
    <tradeName>04046745120609</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10625-245</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T23:43:04.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094290</udiDi>
    <basicUdiDi>B-04046745094290</basicUdiDi>
    <tradeName>04046745094290</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-675</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:46:11.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094283</udiDi>
    <basicUdiDi>B-04046745094283</basicUdiDi>
    <tradeName>04046745094283</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:46:10.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094276</udiDi>
    <basicUdiDi>B-04046745094276</basicUdiDi>
    <tradeName>04046745094276</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-545</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:20.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094269</udiDi>
    <basicUdiDi>B-04046745094269</basicUdiDi>
    <tradeName>04046745094269</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-485</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:20.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094252</udiDi>
    <basicUdiDi>B-04046745094252</basicUdiDi>
    <tradeName>04046745094252</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-430</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:17.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094245</udiDi>
    <basicUdiDi>B-04046745094245</basicUdiDi>
    <tradeName>04046745094245</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-380</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:16.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094238</udiDi>
    <basicUdiDi>B-04046745094238</basicUdiDi>
    <tradeName>04046745094238</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-355</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:16.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094221</udiDi>
    <basicUdiDi>B-04046745094221</basicUdiDi>
    <tradeName>04046745094221</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-330</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:15.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094214</udiDi>
    <basicUdiDi>B-04046745094214</basicUdiDi>
    <tradeName>04046745094214</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-305</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:11.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094207</udiDi>
    <basicUdiDi>B-04046745094207</basicUdiDi>
    <tradeName>04046745094207</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-285</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:10.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094191</udiDi>
    <basicUdiDi>B-04046745094191</basicUdiDi>
    <tradeName>04046745094191</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-250</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:09.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094184</udiDi>
    <basicUdiDi>B-04046745094184</basicUdiDi>
    <tradeName>04046745094184</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-215</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:08.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094177</udiDi>
    <basicUdiDi>B-04046745094177</basicUdiDi>
    <tradeName>04046745094177</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:04.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094160</udiDi>
    <basicUdiDi>B-04046745094160</basicUdiDi>
    <tradeName>04046745094160</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-155</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:04.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094153</udiDi>
    <basicUdiDi>B-04046745094153</basicUdiDi>
    <tradeName>04046745094153</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:03.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094146</udiDi>
    <basicUdiDi>B-04046745094146</basicUdiDi>
    <tradeName>04046745094146</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17727-105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:44:02.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046745094139</udiDi>
    <basicUdiDi>B-04046745094139</basicUdiDi>
    <tradeName>04046745094139</tradeName>
    <deviceName>Mammary implant</deviceName>
    <manufacturerName>POLYTECH Health &amp; Aesthetics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018836</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17726-690</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T22:43:58.463Z</lastUpdated>
  </row>
</eudamedExport>